LeClairRyan's Compliance, Investigations and White Collar team has significant experience representing and advising companies of all sizes in the defense of regulatory agency investigations and enforcement actions, conducting internal investigations and establishing effective corporate compliance. Our practice is national in reach and includes clients from a variety of industries, including, but not limited to: biotechnology, computer technology, defense, energy, healthcare, pharmaceutical, aerospace, telecommunications, hospitality, medical device, and franchise. Several members of our team are former prosecutors, including a high-level federal prosecutor with supervisory experience. Our experience working with high level government officials enables us to assist clients in their interactions with regulators.
Our services include:
Internal Investigations
We frequently are retained by audit committees, special committees and general counsel to conduct internal investigations covering a variety of topics, including alleged financial fraud, Foreign Corrupt Practices Act (FCPA) issues, off-label marketing, average wholesale pricing cases, clinical trial issues, and other issues involving recordkeeping and regulatory compliance. We have conducted investigations for clients in the United States, Europe, South America, the Middle East, and Asia and are familiar with the myriad of issues involved in foreign investigations, including data privacy restrictions.
Our experience and technological capabilities enable us to:
- Assemble and evaluate large amounts of information from witnesses and documents
- Make credibility assessments
- Calculate how prosecutors, regulators and courts most likely will view the conduct at issue
- Recommend whether to disclose the results of the investigation and, if so, the manner in which they should be disclosed
We are fully cognizant of the complex issues facing our clients when they are determining whether to cooperate and waive their attorney-client privilege; accordingly, our experience affords us the capacity to design information-sharing arrangements that will earn the company cooperation credit without needlessly exposing confidential internal communications.
Representation before government agencies
Our team is experienced at defending corporations and individuals under investigation for, charged with, or suspected of criminal law violations. We represent clients before the U.S. Department of Justice and U.S. Attorneys' Offices throughout the nation, state Attorneys General's Offices, local District Attorneys' Offices, and regulatory agencies such as the U.S. Securities Exchange Commission, Federal Trade Commission and U.S. Food and Drug Administration. Our experience and credibility with government prosecutors enables us to frequently negotiate favorable resolutions for our clients, including decisions by the government not to bring charges. We also have significant experience trying criminal cases before juries.
We routinely represent clients who have been subpoenaed to testify before federal and state grand juries. In addition, we help clients respond appropriately and in a timely manner to document subpoenas and search warrants and help prepare them when they are requested by the government to submit to an interview or have a facility inspected. Our significant experience assisting companies when they are faced with these requests diminishes the likelihood of any further and needless disruption to business operations.
Corporate compliance
We routinely advise companies regarding the design, implementation and testing of compliance programs and strategies. Our attorneys have drafted and reviewed corporate ethics and compliance programs and counseled clients on compliance with respect to a variety of laws and regulations, including the FCPA; Sarbanes-Oxley, Dodd-Frank and other securities laws; the Federal Acquisition Regulations; healthcare fraud and abuse statutes; labor regulations; and state and federal antitrust laws. Such preventive assistance is continually updated as we routinely inform our clients of recent developments such as new law enforcement initiatives, U.S. Department of Justice prosecution guidelines and changes to the federal sentencing guidelines as they relate to business enterprises.
Mergers and acquisition (due diligence)
Companies considering an acquisition or merger must carefully consider the ramifications of potential regulatory violations (including FCPA concerns) on transaction valuations and deal execution. Undiscovered illegal conduct may create liability for successors, putting them at risk of prosecution and damaged reputations. Our team supports clients engaged in all manner of transactions by evaluating these potential risks and providing early strategic guidance to help avert later problems.
Representative matters:
- Represented companies before the U.S. Department of Justice and SEC and state Attorneys General's Offices. Representation includes conducting internal investigations, implementing remedial measures and negotiating resolutions
- Represented a biochemical company in an FCPA matter that resulted in non-prosecution agreement for company, a combined fine and disgorgement payment less than the amount the company had reserved, and no compliance monitor
- Represented a company executive under criminal investigation by both the U.S. Attorney's Office for the District of New Jersey and the Attorney General's office resulting in non-prosecution by both offices
- Acted as lead trial counsel in the largest Medicare and Medicaid healthcare carrier case in the U.S. Recovered damages of $144 million for the Federal Insurance Fund
- Defended national healthcare provider in the largest healthcare fraud case for billing fraud violations in the country. Case involved numerous qui tam matters filed in various district courts and involved the review of millions of documents, hundreds of depositions, numerous court hearings, pretrial motions, etc. After five years of responding to grand jury and civil subpoenas and extensive pretrial work, obtained a settlement with the qui tam creditors, the U.S. Department of Justice and client for approximately $800 million, avoided exclusion and minimized criminal indictments.
- Represented international shipping company in an environmental crimes investigation
- Represented several Fortune 100 companies in responding to federal and state grand jury subpoenas
- Represented a corporate officer in a multi-country FCPA investigation resulting in no charges being brought against the officer
- Represented an European trading company in an FCPA investigation resulting in no charges being brought against the company
- Conducted internal investigation on behalf of major pharmaceutical company into allegations involving the off-label promotion of products
- Defended two major hospitals in federal qui tam suits
- Represented a major international pharmaceutical company by providing FCPA advice and conducting internal investigations into allegations of FCPA violations in Asia, South America and Europe
- Designed and implemented comprehensive FCPA compliance programs to prevent and detect potential anti-corruption risks for numerous companies, including (1) developing compliance policies and training programs and (2) drafting and reviewing contracts with agents, distributors and other third parties to ensure they include provisions that require adherence to applicable anti-corruption standards and provide clients with the ability to monitor compliance
Conducted proactive compliance review for a major pharmaceutical company to determine FCPA risks
- Represented a global insurance company in an investigation conducted by the Office of Foreign Asset Control (OFCA) involving potential violations relating to alleged trade with a sanctioned country
- Represented a 501(c)(3) foundation in a matter involving embezzlement by former country director
- Represented a partner of a "Big 4" accounting firm in an SEC investigation concerning reinsurance
- Represented a senior executive of a Swiss-based international reinsurance company in an SEC administrative proceeding
- Represented a former senior executive officer of a German corporation in connection with an SEC investigation and alleged FCPA violations
Defended and investigated procedures by the U.S. Department of Justice for billing irregularity issues. Prevented exclusions and minimized damages to client
- Defended numerous hospitals and healthcare providers in government investigations
- Assisted in the investigation and plea negotiation in one of the largest medical device fraud cases in the state of Virginia
- Major civil litigation involving corporate licensing and government issues
- Criminal and civil matter involving the interpretation of California law with regard to physical therapy treatment
- Represented large hospital in connection with allegations of fraud in reported results of clinical trials